“I was disappointed to learn – while at the Royal Society screening of the documentary, Unrest, in London last Thursday – of the preliminary (but unpublished) results from the phase III clinical trial of Rituximab, that has been carried out in Norway.

“This large, multicentre, ‘gold standard’ clinical trial, involved 152 people with ME/CFS receiving either Rituximab or a placebo, with initial treatment followed by maintenance treatments at 3, 6, 9 and 12 months, and a two year follow up.

“The ME Association has consistently taken the position that Rituximab could be one of the most promising developments in the search for a safe and effective drug treatment that is targeted at the underlying disease process in ME/CFS.

“We also know that the physicians involved in this research – Drs Oystein Fluge and Olav Mella from the Haukeland University Hospital in Norway – have taken great care in the way that they have devised the protocols for the clinical trials that have been carried out and reported.

“Despite the headline negative finding, we believe that this trial will still provide useful insights and contribute to a better understanding of M.E., and we also have the results from the Cyclophosphamide clinical trial to look forward to. We are very pleased that this knowledgeable, and valued, research team will continue with their work, trying to find answers to the M.E. puzzle.

“The ME Association Ramsay Research Fund had set aside around £60,000 to help support this research, or to help fund a clinical trial of Rituximab here in the UK, if such funding was required, and applied for by a reputable research or clinical trials group. No research grant applications have been received.

“It is difficult to comment further on these very basic preliminary results, and my understanding is that no further comment will be made by those involved until the study is published early next year. However, we do believe that it is correct and helpful for the patient community to be notified about the disappointing key conclusions prior to publication.

“Any decision – including if it is going to be sensible for the charity sector to be raising or spending further large sums of money on research involving the theoretical basis to this treatment (i.e. immune system dysfunction, involving the B-cell component of the body’s immune system), or further clinical trials to assess the safety and efficacy of Rituximab – will have to wait until more detailed information becomes available about the outcome of this phase III clinical trial, and the scientists involved have expressed their opinion as to whether further such research is justified.

“Based on the results from the clinical trials that have been published so far – along with the rather mixed evidence from people with M.E. who have been prescribed Rituximab outside formal clinical trials – it does appear that this type of immunotherapy could still be relevant to at least a sub-group.

“If it is agreed by experts in this area of immunotherapeutics (and we will be seeking expert advice), that we should continue to explore the role of Rituximab as a possible treatment for ME/CFS – and try to find immune system biomarkers that could help to identify the sub-group of people with M.E. who are most likely to respond to such treatment – the ME Association will continue to invite applications for research grants to the Ramsay Research Fund.

“Medical journals are less enthusiastic about publishing negative research findings or negative results from clinical trials. However, given the enormous amount of interest in Rituximab, from both people with M.E. and the medical community, I am confident that these results from Norway will be accepted for publication in due course.

“The ME Association is currently considering a number of other research applications – some of them quite large – and trustees will discuss the latest news about the Rituximab clinical trial at their Board meeting in December. A decision will then be made as to whether the £60,000 currently set aside, should remain as a ring-fenced sum for funding Rituximab research, or used for other biomedical research applications.”

Wednesday, 22 November 2017

http://www.investinme.org/IIMER-Newslet-1711-03.shtmlRituximab Trial Status November 2017Norwegian Statement on Phase III TrialProfessor Olav Mella recently publicly released early details from the Phase III multi-centre double-blinded placebo-controlled Rituximab Clinical Trial which has been ongoing in Norway for the past year.Invest in ME Research have been informed by Dr Oystein Fluge of this.Invest in ME Research have issued this preliminary statement (below).The Haukeland team will be presenting at the IIMEC13 13th International ME Conference in London on 1st June 2018Invest in ME Research Initial Statement on Norwegian Phase III Rtiuximab Clinical TrialNovember 21, 2017The statement from Haukeland University, Bergen from Professor Mella is a major disappointment for people with ME and their families.What had looked to be a promising line of research that could lead to an effective treatment for a subgroup of patients defined by the Canadian Criteria and major understanding of the pathology of this disease has proven to be inconclusive.Naturally, at the charity, everyone is disappointed. We are disappointed for all the ME patients and carers and families and friends.We are especially disappointed for all of our supporters and all who have made such generous and tireless efforts to raise funds and awareness of our campaign.We are very disappointed also for the Haukeland research team - a wonderful team who have brought hope to all patients - and, importantly, brought new insight into this disease and new interest from other areas. However, we have found, throughout 12 years of trying to change the way that ME is perceived, researched and treated that it is never easy.It would be easy to give up, to resign oneself to nothing changing, to accept the status quo.But we think differently.At the 2017 Colloquium/Conference we invited Karolinska Institutet in Stockholm to present negative results. Because it is important to use negative results for positive effects. Negative results are data and the Norwegian rituximab trial has generated a lot of data that needs to be looked at very carefully. When we first engaged Professor Jonathan Edwards into research into ME one of the earliest comments he made was that he was pleased to note that our conference did contain negative results.We see the positives in this research which has been performed by researchers of the utmost integrity who have not made headlines for the sake of it but have thoroughly conducted outstanding research, and still retained a humility that is to their credit and that of their colleagues and team.We have an excellent research team in Norway which has served the ME patient community and their families with honesty, integrity, professionalism, detemination and an empathy which had never been seen before in this field.We have established good working relationships between the Norwegian researchers and the UK Centre with input from UCL and UEA/Quadram Institute.We have data now – more than before.We have research which IiMER has established and a foundation for the Centre of Excellence for ME.We have international collaboration in research into ME that will continue.And we have new plans – already in the making.The researchers from Haukeland will give more detail on their results and publish a paper or two which will benefit all studying ME. For us, we have invited the Haukeland team to Norwich to discuss the way forward.We remain positive. Another setback, another day.We have already been in discussion with our advisors and with the Norwegian team and we will meet to clarify the best way forward in the near future with our major funder and researchers.We still have much good research being funded and being planned and feel our stategy is, and will pay off and lead to the most rapid route to finding cause(s) of ME and effective treatments.In another age, and in another struggle which has some parallels to that which is forced upon people with ME, these words strike a chord -“We must accept finite disappointment, but never lose infinite hope. ” - Dr Martin Luther King

Friday, 10 November 2017

The word refuge may be translated "mansion," or "abiding-place," which gives the thought that God is our abode, our home. There is a fulness and sweetness in the metaphor, for dear to our hearts is our home, although it be the humblest cottage, or the scantiest garret; and dearer far is our blessed God, in whom we live, and move, and have our being. It is at home that we feel safe: we shut the world out and dwell in quiet security. So when we are with our God we "fear no evil." He is our shelter and retreat, our abiding refuge. At home, we take our rest; it is there we find repose after the fatigue and toil of the day. And so our hearts find rest in God, when, wearied with life's conflict, we turn to Him, and our soul dwells at ease. At home, also, we let our hearts loose; we are not afraid of being misunderstood, nor of our words being misconstrued. So when we are with God we can commune freely with Him, laying open all our hidden desires; for if the "secret of the Lord is with them that fear Him," the secrets of them that fear Him ought to be, and must be, with their Lord. Home, too, is the place of our truest and purest happiness: and it is in God that our hearts find their deepest delight. We have joy in Him which far surpasses all other joy. It is also for home that we work and labour. The thought of it gives strength to bear the daily burden, and quickens the fingers to perform the task; and in this sense we may also say that God is our home. Love to Him strengthens us. We think of Him in the person of His dear Son; and a glimpse of the suffering face of the Redeemer constrains us to labour in His cause. We feel that we must work, for we have brethren yet to be saved, and we have our Father's heart to make glad by bringing home His wandering sons; we would fill with holy mirth the sacred family among whom we dwell. Happy are those who have thus the God of Jacob for their refuge!

Jennifer Brea's powerful film Unrest exposes the reality of Myalgic Encephalopathy or ME. This condition leaves people utterly exhausted, or as Brea puts it, like a broken battery, unable to charge beyond 10%.

ME is poorly understood and receives minimal research. Brea was repeatedly misdiagnosed and, on one occasion, even told that it was all in the mind - the result of some long-forgotten trauma.

Eventually Brea discovered that there was not only a name for her condition but that there are millions of other people suffering with ME. With the correct diagnosis she has managed to reduce the impact of ME on her life, but she also came to understand how this real disease creates double-barrelled suffering: first, it devastates your life by robbing you of energy; second, the failure of society to respect the reality of your illness makes you invisible and defenceless.

So, why has ME been so badly misunderstood?

Dr Charles Shepherd explains that in the UK two psychiatrists played a particularly damaging role, by treating an outbreak of ME (within a hospital) in 1955 as an example of hysteria. This dangerous desire to solve a problem by evading the problem, has been made all the easier by the emergence of something called the biopsychosocial (BPS) model: this is an all encompassing framework for rethinking illness - making it part biological, part mental, part social. This may seem reasonable, but it easily becomes a way of blaming the victim and claiming it's all in the mind.

The PACE Scandal also demonstrates the powerful forces at work. PACE was a research programme to test two 'therapies' for people with ME - Cognitive Behaviour Therapy (CBT) and Graded Exercise Therapy (GET). Although these therapies did not prove effective, researchers amended the rules of the evaluation so that people who had got worse were counted as having benefited from these therapies.

The UK Government also seems to have a stake in maintaining the belief that ME is all in the mind. Mo Stewart, in her book Cash Not Care, has shown how the US Insurance Company Unum has promoted the BPS model within the DWP, encouraging the UK Government to reduce disability benefits in order to grow the market for their own disability insurance products. Lord Freud cited the PACE research as important evidence to justify the use of BPS in their welfare 'reforms' and medical diagnoses have now been replaced with dubious catch-all assessments of 'readiness for work' or 'level of help.' The film I, Daniel Blake accurately captures many of the horrors of these mindless and inhuman processes.

Fortunately, in the USA, researchers are now taking ME seriously, and making important progress. CBT and GET are no longer recommended as helpful therapies and instead there is increasing recognition that excessive exercise can be extremely dangerous. The level of research is still inadequate, but no one doubts the reality of the illness and important and revealing tests have been developed.

Brea's film, which is winning awards and being widely seen, may help undermine the resistance of the UK establishment, but there is still a long way to go. Even if there are research breakthroughs people will still be living with the disabling consequences of ME. It is for this reason that the Centre for Welfare Reform is supporting the Chronic Illness Inclusion Project. Our aim is to help the community of people suffering from chronic illnesses (including, but going beyond, ME) to find their own voice, to build alliances with other disabled people and to ensure that they are no longer invisible before the eyes of the powerful.

Wednesday, 1 November 2017

LINDA BURNIP and DENISE McKENNA
from Disabled People Against Cuts spotlight how people with ME are having their
health and welfare harmed by poor research and misuse of statistics

LAST week, over 65 deaf and
disabled people’s organisations, campaigns and mental health professionals
wrote to the Prime Minister asking her to urgently rethink her decision to
appoint Professor Sir Simon Wessely to lead the much-anticipated independent
review of the Mental Health Act as announced in her speech at the Conservative
Party conference on October 4.

Wessely’s body of work on myalgic
encephalomyelitis (also known as chronic fatigue syndrome), and his conduct in
relation to people with ME, make him resoundingly unfit to lead an inquiry into
the Mental Health Act.

ME is a poorly understood
illness, believed by most researchers in the field to have a physical cause.
But the “psychiatrisation” of ME through a cognitive-behavioural approach to
the illness led by Wessely since the late 1980s has resulted in treatment
(particularly graded exercise therapy, or GET) which can be harmful and even
coerced, in the stigmatisation of patients and let to the frequent denial of
their entitlement to social security and support.

Wessely has consistently promoted
the unsubstantiated suggestion that ME is caused or maintained by patients’
false illness beliefs and abnormal behaviour.

As a result, the integrity of
patients’ experience of this devastating illness been destroyed as their
testimony is deemed unreliable.

This form of “epistemic
injustice” (according to medical ethics scholars Blease et al) has seen people
with ME derided within the medical profession and wider society for
misperceiving, exaggerating, even creating their own illness.

Wessely’s approach to ME involves
treatment with GET, aimed at reversing the physical consequences of what he
sees as their dysfunctional behaviour.

Nearly 50 per cent of people with
ME surveyed reported that treatment with GET made their condition worse.

Yet Wessely and his colleagues
are silent on the subject or dismiss patient experience as unreliable evidence
or poor treatment compliance.

As a result, thousands of people
with ME have received NHS treatment informed by his model that has further
damaged their health.

Wessely continues to defend the
notorious Pace trial, a study into CBT and GET treatment for ME/CFS part-funded
by the Department for Work and Pensions and widely condemned by academics for
misuse of statistical methods in order to produce positive-looking results.

Wessely’s involvement in media
discussions about ME has further suppressed patients’ voices. Following the
publication of results from the Pace trial, Wessely and his colleagues
responded to concerns about their work by taking part in media campaign which
promoted prejudice and led to those patients who had identified serious
methodological and statistical problems being dismissed as irrational
extremists motivated by anti-psychiatry.

The Science Media Centre, for
which Wessely is a trustee, has played a key role in promoting misleading
information about the Pace trial, and smearing critics.

During the 1990s Wessely advised
the DWP (then DSS) that classifying ME as a neurological illness, as the World
Health Organisation does, would perpetuate patients’ false beliefs, prolong
their illness and result in a deluge of disability claims.

The influence of Wessely and his
colleagues on DWP training manuals on CFS/ME has undoubtedly resulted in a
disability assessment system biased against people with ME and caused them
great additional difficulty in accessing support with the extra costs of their
disability.

The work of Jonathan Rutherford
reveals how Wessely was among a group of medical and insurance industry
professionals whose work on “malingering and illness deception” influenced the
DWP’s understanding of ill-health and disability.

Wessely and his colleagues shaped
the ideology underpinning the disastrous work capability assessment (WCA) known
as the “biopsychosocial model.” According to Professor Tom Shakespeare and
colleagues who have exposed the poor science underpinning the biopsychosocial
model, this approach to disability effectively blames disabled people seeking
social security support for their own misfortune.

The WCA has had a devastating
impact on the lives of disabled people as part of a package of welfare reforms
leading, in the words of the UN disability committee, to “human catastrophe.”

All of these activities amount to
an abuse of power by Wessely against people with ME. His thoughts and actions
have led to stigma, iatrogenesis and a denial of their rights to support, all
of which have compounded the burden of this illness immeasurably.

About Me

I am a Christian, saved by grace alone through faith alone. I have had the neuroimmune disorder ME, Myalgic Encephalomyelitis, since 1991. From North Somerset, now in N. Ireland. Please see my website for further information about ME.